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Completed

NCT Number: NCT00135304

ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism

The purpose of this study is to compare the proportion of chronic kidney disease (CKD) subjects on dialysis receiving Sensipar® and low dose vitamin D or escalating doses of vitamin D alone who are able to achieve the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI) secondary hyperparathyroidism (HPT) treatment targets for both biointact parathyroid hormone (biPTH) and calcium-phosphorus (Ca x P) product.

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Key information

Conditions

Secondary Hyperparathyroidism Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- On hemodialysis for at least 3 months and have received intravenous vitamin D therapy (paricalcitol or doxercalciferol) for at least 3 months prior to entering screening - Historical iPTH 150-800 pg/ml (or biPTH 80-430 pg/ml) within 6 months and corrected serum Ca greater than 8.4 mg/dl within 2 months prior to screening period. For subjects with biPTH 80-160 pg/ml (iPTH 150-300 pg/ml), Ca x P must be greater than 55 mg²/dl² within 2 months prior to the screening period - Screening (pre-washout) biPTH 80-430 pg/ml and a corrected serum Ca level greater than 8.4 mg/dl. For subjects with biPTH 80-160 pg/ml Ca x P must be also greater than 55 mg²/dl² - Baseline mean biPTH (post-washout) greater than 160 pg/ml and mean corrected Ca greater than 8.4 mg/dl Exclusion Criteria: - Parathyroidectomy in the 3 month period prior to screening - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Use of investigational drug or device or participation in a trial of investigational drug or device within 30 days of screening - Females of child bearing potential who are pregnant (e.g., positive pregnancy test) or are breast feeding or who refuse to use highly effective contraceptive measures (as determined by the investigator) throughout the study - Previously participated in this or any other Sensipar® study or has received or is receiving Sensipar® as a commercially available product

Treatment and study plan

Sensipar®

Drug

Cinacalcet hydrochloride

Other names: Cinacalcet hydrochloride, Cinacalcet HCL, Cinacalcet

Vitamin D

Drug

Vitamin D administered IV

Other names: paricalcitol, doxercalciferol

Primary outcomes

  1. Achieving the NKF-K/DOQI targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (less than 55 mg^2/dL^2) during the assessment phase

    Time frame: Weeks 17 - 27

    Proportion of subjects in each treatment group simultaneously achieving the National Kidney Foundation - Kidney Disease Outcome Quality Initiative (NKF-K/DOQI) targets for both biPTH (80-160 pg/mL, equivalent to iPTH 150-300 pg/mL) and Ca x P (< 55 mg^2/dL^2) during the assessment phase (last 11 weeks of study following a 16-week titration phase)

Secondary outcomes

  1. Absolute Change from Baseline for P During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Absolute change from baseline for serum phosphorus (P) during the assessment phase

  2. Proportion of Participants with ≥ 30% Reduction from Baseline in Mean iPTH During the Assessment Phase

    Time frame: Baseline and Weeks 17-27

    Proportion of participants with ≥ 30% reduction from baseline in mean intact parathyroid hormone (iPTH) during the assessment phase.

  3. Percent Change from Baseline for Calcium During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Percent Change from Baseline for Calcium (Ca) During the Assessment Phase

  4. Percent Change from Baseline for Phosphorus During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Percent change from baseline for Phosphorus (P) during the assessment phase

  5. Percent Change from Baseline for Ca x P During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Percent change from baseline for calcium x phosphorus (Ca x P) during the assessment phase

  6. Percent Change from Baseline for iPTH During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Percent change from baseline for intact parathyroid hormone (iPTH) during the assessment phase

  7. Proportion of Participants who Attained the K/DOQI Target Range for Ca x P During the Assessment Phase.

    Time frame: Weeks 17 - 27

    Proportion of participants who attained the K/DOQI target range for calcium x phosphorus (Ca x P) during the assessment phase.

  8. Proportion of Participants who Attained the K/DOQI Target Range for Ca During the Assessment Phase

    Time frame: Weeks 17-27

    Proportion of participants who attained the K/DOQI target range for calcium (Ca) during the assessment phase.

  9. Proportion of Participants who Attained the K/DOQI Target Range for iPTH During the Assessment Phase

    Time frame: Weeks 17-27

    Proportion of participants who attained the K/DOQI target range for intact parathyroid hormone (iPTH) during the assessment phase.

  10. Proportion of Participants who Attained the K/DOQI Target Range for P During the Assessment Phase.

    Time frame: Weeks 17-27

    Proportion of participants who attained the K/DOQI target range for phosphorus (P) during the assessment phase.

  11. Absolute Change from Baseline for iPTH During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Absolute change from baseline for intact parathyroid hormone (iPTH) during the assessment phase.

  12. Absolute Change from Baseline for Ca During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Absolute change from baseline for calcium (Ca) during the assessment phase

  13. Absolute Change from Baseline for Ca x P During the Assessment Phase

    Time frame: Baseline to weeks 17-27

    Absolute change from baseline for calcium x phosphorus (Ca x P) during the assessment phase.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

ACHIEVE: Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar® and Low Dose Vitamin D vs. Escalating Doses of Vitamin D Alone

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 26, 2005
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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